RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as flutamide, bicalutamide, and luteinizing hormone-releasing hormone agonist, may lessen the amount of androgens made by the body. It is not yet known which regimen of radiation therapy with or without androgen-deprivation therapy is more effective for prostate cancer.

PURPOSE: This randomized phase III trial is studying prostate radiation therapy to see how well it works compared with short-term androgen deprivation therapy given together with pelvic lymph node radiation therapy with or without prostate radiation therapy in treating patients with a rising PSA after surgery for prostate cancer.

Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:

Freedom from progression (FFP) [ Time Frame: From date of randomization to the first occurrence of biochemical failure by the Phoenix definition (PSA >= 2 ng/ml over the nadir PSA), clinical failure (local, regional or distant) or death from any cause. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Secondary biochemical failure [ Time Frame: From date of randomization to a detectable PSA rising for at least two values with the second value at 0.4 ng/mL or greater. ] [ Designated as safety issue: No ]

Hormone-refractory disease [ Time Frame: From the date of randomization to the third of three rises of PSA after the institution of salvage hormone therapy. ] [ Designated as safety issue: No ]

Local failure [ Time Frame: From the date of randomization to the development of a new palpable abnormality in the prostate bed after enrollment in the protocol. ] [ Designated as safety issue: No ]

Cause-specific mortality [ Time Frame: From date of randomization to the date of death due to prostate cancer. ] [ Designated as safety issue: No ]

Overall mortality [ Time Frame: From the date of randomization to the date of death due to any cause. ] [ Designated as safety issue: No ]

Incidence of acute adverse events ≤ 90 days of the completion of radiotherapy (RT) [ Time Frame: From the date radiation treatment completion to the first occurrence of worst severity of an adverse event within 90 days. ] [ Designated as safety issue: Yes ]

Time to late grade 2+ and 3+ adverse events assessed > 90 days from the completion of RT [ Time Frame: From date of randomization to the first occurrence of grade 2+ or 3+ adverse event > 90 days after the radiation therapy completion date. ] [ Designated as safety issue: Yes ]

Assessment of mood and depression change using QOL measured by the Hopkins Symptom Checklist (HSCL-25) [ Time Frame: From the 6th week of radiation therapy to 5 years post radiation therapy. ] [ Designated as safety issue: No ]

Assessment and comparison of Quality Adjusted Life Year (QALY) and Quality Adjusted FFP Year (QAFFPY) [ Time Frame: From the 6th week of radiation therapy to 5 years post radiation therapy. ] [ Designated as safety issue: No ]

Evaluation and comparison of the cost-utility using EuroQoL - 5 Dimensions (EQ-5D) [ Time Frame: From the 6th week of radiation therapy to 5 years post radiation therapy. ] [ Designated as safety issue: No ]

Association between serum levels of beta-amyloid (Abeta) and measures of HSCL-25, the HVLT-R, Trail Making Test, parts A & B, or the COWAT [ Time Frame: From the 6th week of radiation therapy to 5 years post radiation therapy. ] [ Designated as safety issue: No ]

Prognostic value of genomic and proteomic markers for the primary and secondary clinical endpoints [ Time Frame: Date of randomization to timepoint of the respective primary or secondary endpoint. ] [ Designated as safety issue: No ]

Assessment of the relationship(s) between the American Urological Association Symptom Index (AUA SI) and urinary morbidity (Adverse Event terms: Urinary frequency/urgency) using the CTCAE v. 3.0 grading system [ Time Frame: From the 6th week of radiation therapy to 5 years post radiation therapy. ] [ Designated as safety issue: Yes ]

(PBRT and short-term androgen deprivation [STAD]): Beginning 2 months before the start of PBRT, patients undergo STAD, using a combination of antiandrogen (AA) and LHRH agonist therapy, for a total of 4-6 months. Patients receive AA therapy comprising either oral flutamide 3 times daily or oral bicalutamide once daily for at least 4 months. Patients receive LHRH agonist injection beginning concurrently with or 2 weeks after the start of AA therapy. LHRH agonist injection consists of analogs approved by the FDA (or by Health Canada for Canadian institutions) (e.g., leuprolide, goserelin, buserelin, or triptorelin) and may be given in any possible combination (may be given as a single 4-month injection and one to two 1-month injection[s], two 3-month injections, or a 6-month injection), such that the total LHRH agonist treatment time is 4-6 months. Approximately 2 months after beginning of STAD, patients undergo PBRT as in arm I.

Drug: bicalutamide

Oral, daily

Drug: flutamide

Oral, daily

Radiation: radiation therapy

Once daily, 5 days a week

Experimental: Arm III

(Pelvic lymph node radiotherapy [PLNRT], PBRT, and STAD): Beginning 2 months before the start of radiotherapy, patients receive STAD therapy as in arm II. Approximately 2 months after beginning of STAD, patients undergo PBRT and PLNRT once daily, 5 days a week, Monday through Friday, for approximately 5 weeks (25 fractions) followed by PBRT only once daily, 5 days a week for approximately 2-3 weeks (11-14 fractions).

Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition

HIV testing is not required for entry

No prior allergic reaction to the study drug(s) involved in this protocol

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

More than 5 years since prior chemotherapy for any other disease site

No androgen-deprivation therapy started prior to prostatectomy for > 6 months duration

The use of finasteride or dutasteride (± tamsulosin) for longer periods prior to prostatectomy is acceptable

No androgen-deprivation therapy started after prostatectomy and prior to registration

The use of finasteride or dutasteride (± tamsulosin) after prostatectomy is not acceptable, it must be stopped within 3 months after prostatectomy

No neoadjuvant chemotherapy before or after prostatectomy

No prior cryosurgery or brachytherapy of the prostate (prostatectomy should be the primary treatment and not a salvage procedure)

No prior pelvic radiotherapy

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00567580